To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Device Description

Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.

Electronic Muscle Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.

The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

AI/ML Overview

This document is a 510(k) Summary for an Electronic Muscle Stimulator, demonstrating substantial equivalence to a predicate device. It is not a report for an AI-powered medical device and therefore does not contain information typically found in such reports regarding acceptance criteria for AI performance, specific studies with test sets, expert ground truth establishment, MRMC studies, or training set details.

Based on the provided text, here's what can be extracted, and where limitations exist:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, AUC). Instead, it compares the subject device's specifications to those of a predicate device to demonstrate substantial equivalence. The acceptance is implicitly shown by meeting the same or similar specifications as the already cleared predicate device, and demonstrating that any differences do not raise new safety or effectiveness issues.

Here is a table based on the "Elements of Comparison" between the Subject Device and Predicate Device, which serves as the "performance" for this type of device:

Acceptance Criteria (e.g., Predicate Device Performance)	Reported Device Performance (Subject Device)	Remark
Device Name and Model: Health Expert Electronic Stimulator Model: AST-300F, AST-300H, AST-300J	Electronic Muscle Stimulator Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W	--
510(k) Number: K190673	Applying (K211736)	--
Intended Use (PMS): To stimulate healthy muscles to improve and facilitate muscle performance.	Same	SE (Substantially Equivalent)
Intended Use (TENS): Temporary relief of pain associated with sore and aching muscles in shoulder, waist, back, neck, arm, leg, foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.	Same	SE
Power Source(s): Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A	Same	SE
Method of Line Current Isolation: Type BF Applied Part	Same	SE
Patient Leakage Current (NC): AC: 54.5 µA, DC: 0 µA	AC: 54.5 µA, DC: 0.5 µA	SE
Patient Leakage Current (SFC): AC: 120.0 µA, DC: 0 µA	AC: 120.0 µA, DC: 0.6 µA	SE
Average DC current through electrodes (device on but no pulses): < 0.01 µA	Same	SE
Number of Output Channels: 2	Same	SE
Number of Output Modes: 25	Same	SE
Output Intensity Level: 99 steps	Same	SE
Synchronous or Alternating?: Synchronous	Same	SE
Method of Channel Isolation: Voltage Transform Isolation, "Body+" and "Body-" buttons for body channel, "Sole+" and "Sole-" buttons for feet channel	Same	SE
Regulated Current or Regulated Voltage?: Voltage Control	Same	SE
Software/Firmware/Microprocessor Control?: Yes	Yes	SE
Automatic Overload Trip: No	No	SE
Automatic No-Load Trip: No	No	SE
Automatic Shut Off: Yes	Yes	SE
User Override Control: Yes	Yes	SE
Indicator Display (On/Off Status): Yes	Yes	SE
Indicator Display (Low Battery): No	No	SE
Indicator Display (Voltage/Current Level): Yes	Yes	SE
Timer Range: 25 min (default)	AST-300N, AST-300S, AST-300T, AST-300V: 25 min (default); AST-300A and AST-300W: can adjust the time (5-25min)	SE
Weight: 1.9Kg (Without accessories)	Varies by model (e.g., AST-300A: 1.62kg, AST-300W: 1.99kg)	SE Note (Differences do not raise safety/effectiveness issues)
Dimensions: 429.1mm x 426.6mm x 153.8mm	Varies by model (e.g., AST-300A: 209.7x215.3x52.3mm, AST-300W: 464.7x419.6x181mm)	SE Note (Differences do not raise safety/effectiveness issues)
Housing Materials and Construction: Main unit: ABS plastic	Same	SE
Waveform: Pulsed, symmetric, biphasic	Same	SE
Shape: Rectangular, with interphase interval	Same	SE
Maximum Output Voltage: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±20% @ 10KΩ	44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ	SE (Note: Subject device's 10KΩ tolerance is ±10% vs predicate's ±20%, meaning it's tighter, which is acceptable)
Maximum Output Current: 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ	Same	SE
Pulse width: 120µs	Same	SE
Pulse frequency: 77.3Hz	Same	SE
Net Charge (per pulse): 0µC @ 500Ω; Method: Balanced waveform	Same	SE
Maximum Phase Charge: 10.56μC @ 500Ω	Same	SE
Maximum Average Current: 1.63mA @ 500Ω	Same	SE
Maximum Current Density (r.m.s): 0.0326mA/cm² @ 500Ω	Same	SE
Maximum Average Power Density: 0.0000266mW/cm² @ 500Ω	Same	SE
ON Time: 0.6s	Same	SE
OFF Time: 0.6s	Same	SE
Environment for operating: Temperature: 5 ~ 45° C; Humidity: 20 ~ 65% RH	Same	SE
Environment for storage: Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C	Same	SE
Biocompatibility: All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	Same	SE
Electrical Safety: Comply with IEC 60601-1 and IEC 60601-2-10	Same	SE
EMC: Comply with IEC 60601-1-2	Same	SE

2. Sample sizes used for the test set and the data provenance:

Sample Size: Not applicable. This submission relies on substantial equivalence to an existing device, not a new clinical study.
Data Provenance: Not applicable for a typical "test set" as understood for AI performance. The provenances relate to the standards adherence (e.g., IEC, ISO standards for electrical safety, EMC, biocompatibility) through lab bench testing. The country of origin of the device manufacturer is China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is an Electronic Muscle Stimulator, not a device that processes complex data (like medical images) requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set requiring adjudication of findings is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of device, "ground truth" is established by adherence to recognized performance and safety standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility). The testing mentioned (Electrical safety, EMC, Biocompatibility, Usability, Software V&V) are based on these established engineering and safety requirements.

8. The sample size for the training set:

Not applicable. This device does not use an AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 5, 2021

Shenzhen OSTO Technology Company Limited % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou City Guangdong, China

Re: K211736

Trade/Device Name: Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: May 31, 2021 Received: June 7, 2021

Dear Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211736

Device Name

Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300T, AST-300T, AST-300V, AST-300W)

Indications for Use (Describe)

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 9~25)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for K211736

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Shenzhen OSTO Technology Company Limited �
Establishment Registration Number: 3011564440 �
� Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District, Shenzhen City, Guangdong Province, China
Tel: +86-755-29769546 �
� Fax: +86-755-29769540
Contact Person: Li Yang (General Manger) �
� Email: annaosto@163.com

Application Correspondent: 2.

� Contact Person: Ms. Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. �
� Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China
Tel: +86 20 8266 2446 �
Email: regulatory@glomed-info.com �

3. Subject Device Information

Electronic Muscle Stimulator � Trade Name:
Electronic Stimulator Common Name: �
Stimulator, Nerve, Transcutaneous, Muscle, Powered, For �
- Classification name: Muscle Conditioning, Over-The-Counter
Neurology, Physical Medicine Review Panel: �

NUH, NGX Product Code: �
� Regulation Class:
882.5890, 890.5850 Regulation Number: �

4. Predicate Device Information

Sponsor Shenzhen OSTO Technology Company Limited � Health Expert Electronic Stimulator � Device Name and Model Model: AST-300F, AST-300H, AST-300J

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510(k) Number K190673 �
NUH, NGX Product Code �
� Regulation Number 882.5890, 890.5850
� Requlation Class II

2. Device Description

Electronic Muscle Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.

The models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.

5. Intended Use / Indications for Use

PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 9~25)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

6. Test Summary

6.1 Non-clinical testing was conducted to verify that the subject device met all design specifications, demonstrated safety based on current industry standards, and to

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demonstrate substantial equivalence to the predicate. The following tests were performed:

Electronic Muscle Stimulator has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 � standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
� Usability test according to IEC 62366-1 standard
� Software verification and validation test according to the requirements of the FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"

6.2 Summary of Clinical Performance Test

No clinical study is included in this submission.

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electronic Muscle Stimulator is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements of Comparison	Subject Device	Predicate Device	Remark
Device Name and Model	Electronic MuscleStimulatorModel: AST-300A,AST-300N, AST-300S,AST-300T , AST-300V,AST-300W	Health Expert ElectronicStimulatorModel: AST-300F,AST-300H, AST-300J	--
510(k) Number	Applying	K190673	--
Intended Use	PMS (Mode 1~~8)It is intended to stimulatehealthy muscles in orderto improve and facilitatemuscle performance.TENS (Mode 9~~25)	PMS (Mode 1~~8)It is intended to stimulatehealthy muscles in order toimprove and facilitatemuscle performance.TENS (Mode 9~~25)	SE
Elements of Comparison	Subject Device	Predicate Device	Remark
To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, back of theneck, arm, leg, and footdue to strain fromexercise or normalhousehold work activitiesby applying current tostimulate nerve.	To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, back of theneck, arm, leg, and foot dueto strain from exercise ornormal household workactivities by applyingcurrent to stimulate nerve.
Power Source(s)	Adaptor Input:100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	Adaptor Input: 100-240Vac,50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	SE
-Method of Line Current Isolation	Type BF Applied Part	Type BF Applied Part	SE
Patient LeakageCurrent	NC	AC: 54.5 $\mu$ A, DC: 0 $\mu$ A	AC: 54.5 $\mu$ A, DC: 0.5 $\mu$ A	SE
	SFC	AC:120.0 $\mu$ A, DC: 0 $\mu$ A	AC:120.0 $\mu$ A, DC: 0.6 $\mu$ A
Average DC current throughelectrodes when device is on butno pulses are being applied	< 0.01 $\mu$ A	< 0.01 $\mu$ A	SE
Number of OutputChannels:	2	2	SE
Number of Output Modes	25	25	SE
Output Intensity Level	99 steps	99 steps	SE
Synchronous or Alternating?	Synchronous	Synchronous	SE
Elements of Comparison		Subject Device	Predicate Device	Remark
Method of Channel Isolation		Voltage TransformIsolation"Body+" and "Body-"buttons for body channel,"Sole+" and "Sole-"buttons for feet channel	Voltage Transform Isolation"Body+" and "Body-"buttons for body channel,"Sole+" and "Sole-" buttonsfor feet channel	SE
Regulated Current or RegulatedVoltage?		Voltage Control	Voltage Control	SE
Software/Firmware/MicroprocessorControl?		Yes	Yes	SE
Automatic Overload Trip		No	No	SE
Automatic No-Load Trip		No	No	SE
Automatic Shut Off		Yes	Yes	SE
User Override Control		Yes	Yes	SE
Indicator Display	On/Off Status	Yes	Yes	SE
	Low Battery	No	No	SE
	Voltage/Current Level	Yes	Yes	SE
Timer Range		AST-300N, AST-300S,AST-300T andAST-300V: 25 min(default);AST-300A andAST-300W: can adjustthe time (5-25min)	25min	SE
Weight		AST-300A: 1.62kgAST-300N: 1.5kgAST-300S: 1.23kgAST-300T: 1.92kgAST-300V: 1.93kgAST-300W: 1.99kg	1.9Kg (Withoutaccessories)	SE Note
Dimensions		AST-300A:	429.1mm x 426.6mm x153.8mm	SE Note
Elements of Comparison	Subject Device	Predicate Device	Remark
	209.7215.352.3mmAST-300N:403.7402.647.3mmAST-300S:345.5316.174.2mmAST-300T:401.9401.3158.9mmAST-300V:464.6419.6181.0mm
	AST-300W:464.7419.6181mm
Housing Materials andConstruction	Main unit: ABS plastic	Main unit: ABS plastic	SE
Waveform	Pulsed, symmetric,biphasic	Pulsed, symmetric, biphasic	SE
Shape	Rectangular, withinterphase interval	Rectangular, withinterphase interval	SE
Maximum Output Voltage	44V±10% @ 500Ω	44V±10% @ 500Ω	SE
	80V±10% @ 2KΩ	80V±10% @ 2KΩ	SE
	112V±10% @ 10KΩ	112V±20%@ 10KΩ	SE
Maximum Output Current	88mA±10% @ 500Ω	88mA±10% @ 500Ω	SE
	40mA±10% @ 2KΩ	40mA±10% @ 2KΩ	SE
	11.2mA±10% @ 10KΩ	11.2mA±10% @ 10KΩ	SE
Pulse width	120µs	120µs	SE
Pulse frequency	77.3Hz	77.3Hz	SE
Net Charge (per pulse)	0µC @ 500ΩMethod: Balancedwaveform	0µC @ 500ΩMethod: Balancedwaveform	SE
Maximum Phase Charge	10.56μC @ 500Ω	10.56μC @ 500Ω	SE
Maximum Average Current	1.63mA @ 500Ω	1.63mA @ 500Ω	SE
Elements of Comparison	Subject Device	Predicate Device	Remark
Maximum Current Density(r.m.s )	0.0326mA/cm² @ 500Ω	0.0326mA/cm2 @500Ω	SE
Maximum Average Power Density	0.0000266mW/cm² @500Ω	0.0000266mW/cm² @500Ω	SE
ON Time	0.6s	0.6s	SE
OFF Time	0.6s	0.6s	SE
Environment for operating	Temperature: 5 ~ 45° CHumidity: 20 ~ 65% RH	Temperature: 5 ~ 45°CHumidity: 20 ~ 65% RH	SE
Environment for storage	Temperature: 0 ~ 45°C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20°C	Temperature: 0 ~ 45°C,Humidity: 10 ~ 90% RHElectrode Pad: 10~20°C	SE
Biocompatibility	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10 requirements.	SE
Electrical Safety	Comply with IEC60601-1 and IEC60601-2-10	Comply with IEC 60601-1and IEC 60601-2-10	SE
EMC	Comply with IEC60601-1-2	Comply with IEC 60601-1-2	SE

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Comparison in Detail(s):

Note:

Although the "Weight" and "Dimensions" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.

Final Conclusion:

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The subject devices "Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) are Substantial Equivalent to the predicate device K190673.

8. Date of the summary prepared: September 2, 2021

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).